Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer

NCT01593293 | Unknown Phase 3

• 1 other identifier: AMC 2011-0857
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.

Conditions

Non-small Cell Lung Cancer

Keywords

Elderly patients; Non-squamous Non-small Cell Lung Cancer; Pemetrexed; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  To compare the progression free survival of elderly patients (≥70 years old) with non-squamous NSCLC receiving doublet of carboplatin and pemetrexed to patients receiving pemetrexed alone.

  The study lasts for 30 months of which subject accrual occurs in the first 24 months

Secondary Outcomes (1)

• Objective response rate, Overall survival, Safety and Quality of life

  The study lasts for 30 months of which subject accrual occurs in the first 24 months

Study Arms (2)

PemCarbo

ACTIVE COMPARATOR

Pemetrexed/Carboplatin arm

Drug: PemCarbo

Pem only

ACTIVE COMPARATOR

Pemetrexed arm

Drug: Pem only

Interventions

PemCarbo DRUG

Pemetrexed 500mg/m2, Carboplatin AUC5 intravenously q 3 weeks for 4 cycles, followed by pemtrexed 500mg/m2 q 3 weeks for maintenance therapy

Also known as: Alimta: brand name of Pemetrexed

PemCarbo

Pem only DRUG

Pemetrexed 500mg/m2 intrvenously q 3 weeks till progression or unacceptable toxicity.

Also known as: Alimta: brand name of pemetrexed

Pem only

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically confirmed advanced non-squamous non-small cell lung cancer (stage IV, AJCC 7th)
• Age 70 years old or older
• Eastern Cooperative Oncology Group performance status 0-1
• Measurable or assessable disease as defined by RECIST 1.1
• Estimated life expectancy of more than 3 months
• Adequate bone marrow function(Absolute Neutrophil Count (ANC) ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobulin ≥ 9 g/dL)
• Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance(Ccr) using Cockroft and Gault formula ≥45 ml/min
• Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \< 3 x UNL, alkaline phosphatase \< 3 x UNL (except in case of bone metastasis without any liver disease)
• Written informed consent

You may not qualify if:

• Prior systemic chemotherapy or biological therapy
• Contraindication to any drug contained in the chemotherapy regimen
• Clinically significant third-space fluid collections (e.g. pleural effusion and pericardial effusion) that cannot be controlled by drainage or other procedures prior to study enrollment
• Active infection which would compromise the patient's ability to tolerate treatment
• Requirement for major surgery within 4 weeks of study entry
• Myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months
• Unable to discontinue administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); Aspirin or NSAIDs should be at least 5 days before pemetrexed administration
• Presence or history of CNS metastasis (except if adequately treated and is not receiving steroid therapy for at least 2 weeks; at least 2 weeks for whole brain radiation or at least 1 week for gamma knife surgery)
• Peripheral neuropathy ≥ grade 2
• History of another malignancy within the last five years except cured basal cell carcinoma of skin, cured carcinoma in-situ of uterine cervix and cured thyroid malignancy
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Other serious illness or medical conditions

Sponsors & Collaborators

• Asan Medical Center: lead
• Eli Lilly and Company: collaborator
• Korean Cancer Study Group: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sang-We Kim, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-We Kim, M.D.

CONTACT

82-2-3010-3215; swkim@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: May 8, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2015
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

KR (1)